This early-phase trial examined whether aleglitazar could be of benefit for the treatment of type 2 diabetes. The authors concluded that aleglitazar improves both blood glucose and cholesterol levels among diabetic patients.

As of 2013, all further drug development of aleglitazar was halted by Roche, and all phase 3 trials were stopped. The preliminary results of the phase 3 trials that were halted were also recently published, and a pooled analysis concluded that "Development of aleglitazar was halted because of a lack of cardiovascular efficacy and side effects in patients with type 2 diabetes post-acute coronary syndrome (heart attack); however, in the present studies, aleglitazar was well tolerated and effective in improving HbA1c, insulin resistance and lipid variables".

Patients with type 2 diabetes initially produce adequate insulin (a hormone which lowers blood sugar levels). However, insulin sensitivity (the effect of insulin on the cells of the body) decreases over time. Drugs such as metformin (Glucophage) aim to increase insulin sensitivity. However, metformin may not adequately improve blood glucose levels and patients may benefit from additional drug therapy.

Aleglitazar is a new class of drug which is believed to increase insulin sensitivity, and reduce cholesterol levels. The safety and effectiveness of aleglitazar in treating type 2 diabetes was evaluated in this early-phase clinical trial.

This study involved 38 patients with type 2 diabetes. Participants were divided into 2 groups. One group received 150 µg aleglitazar once daily for 16 weeks. The other group received a placebo (a substance with no therapeutic effect). All participants were also taking metformin. Insulin sensitivity, HbA1c levels, cholesterol levels and body mass were measured before and after treatment.

After 16 weeks, insulin sensitivity was increased in participants treated with aleglitazar compared to the placebo group. HbA1c was significantly improved in participants treated with aleglitazar (-0.48%) compared to the placebo group (-0.01%). LDL cholesterol (often referred to as the ‘bad cholesterol’) levels were lower after treatment in participants who received aleglitazar (-6%) compared to participants in the placebo group (+4.2%).

Overall, aleglitazar was well-tolerated. 44.8% of participants treated with aleglitazar reported experiencing mild to moderate side effects, compared to 32% of patients receiving a placebo. Authors concluded that reported side-effects were unrelated to aleglitazar treatment. Participants treated with aleglitazar did show increased weight (+1.43 kg) after treatment compared to the placebo group (-0.70 kg).

This study concluded that aleglitazar improves insulin sensitivity, blood glucose and cholesterol levels among type-2 diabetics.

Several of the investigating authors of this study were employed by Roche, the company which developed aleglitazar.